Jennifer McCaffrey Ph.D.

Expertise

Ten years of academic research experience in pharmacology and toxicology on the effect of drugs and carcinogens on mammalian systems and oncogenic disease processes.
Nine years in the pharmaceutical industry, including seven years supervisory experience.
Conducting preclinical drug-metabolism and pharmacokinetic studies and implementing new methodologies.
Conducting HPLC and LC/MS/MS-based sample analysis in a GLP laboratory
Data analysis and database management for Haemophilus Influenzae Type b (Hib) Vaccine Efficacy Trial.
Project leader for multi-site and multi-disciplinary Lead Optimization project team.

Professional Experience

May 2007 - Present

Pharmacologist
Salamandra, LLC, Bethesda, MD

Responsible for authoring nonclinical pharmacology, nonclinical pharmacokinetics, in vitro ADME and transporter sections of regulatory submissions (Briefing Packages, IND, NDA).
Responsible for designing, placing, monitoring and reviewing in vitro ADME and transporter studies. Provide independent, expert interface between pharmaceutical companies and CROs. Conduct gap analysis for compliance of studies with FDA 2006 Drug Interaction Guidance.
Direct and evaluate searches of the worldwide literature tailored to needs of clients and for regulatory submissions.

2003 -
May 2007

Scientist III / Associate Director, DMPK
Scientist II / ADME Group Leader, DMPK
NPS Pharmaceuticals, Inc., Salt Lake City, Utah

Provided overall support in determining in vitro and in vivo ADME characteristics of potential drug candidates during pre- and post- IND phases of drug development.
Supervised staff conducting preclinical in vitro and in vivo ADME studies (Phase I and Phase II metabolism, CYP450 inhibition, mechanism based CYP450 inhibition, CYP450 induction, and metabolite identification studies; plasma protein binding studies; Caco-2 cell absorption and MDR1 transporter assays and in vivo pharmacokinetic studies in rodents).
Served as the primary DMPK departmental representative on Discovery Research Division project teams for both internal projects and external collaborations. Collaborated with chemists, pharmacologists, toxicologists and clinical pharmacokinetics personnel. Provided perspective and recommendations to team members as to how the DMPK results fit into the larger drug discovery picture.
Successfully led multi-site and multi-disciplinary Lead Optimization project team to preclinical candidate selection stage ahead of corporate goal.
Assessed priorities across projects and adjusted the workload distribution within the group and across disciplines.
Reviewed and reported the results of the studies conducted by the ADME group to project teams on a timely basis.
Assisted in conducting due diligence research on external research prospects.
Researched new technologies and implemented as needed.

2000 -
2003

Scientist II, Pre-clinical Services
Scientist I, Pre-clinical Services
PPD Discovery, Morrisville, NC

Setup new laboratory including purchasing equipment, training personnel, establishing assay protocols, writing Discovery operating guidelines and developing report templates.
Assisted in establishing business from scientific perspective by writing technical sales sheets and assembling cost-estimate calculation sheets.
Project Management. Discussing study goals with sponsor, tailoring the proposals to fit sponsor's needs, writing study protocols, coordinating resource needs and scheduling.
Supervised employees conducting in vitro drug-metabolism, protein binding and permeability studies for sponsors; running hundreds of assays yearly.
Diagnosed assay and sample analysis problems; readjusted resources as necessary.
Completed studies by reviewing data, writing reports, and discussing implications of results with sponsor.

1998 -
2000

Senior Scientist, R&D / Bioanalytical Division
PPD Development, Inc., Middleton, WI

Developed initial format of basic metabolism assays (completed after transfer to PPD Discovery in Morrisville, NC)
Conducted HPLC or LC/MS/MS based sample analysis projects for GLP bioanalytical laboratory.

1994 -
1998

Postdoctoral Research Fellow, Dept. of Anatomy
University of Wisconsin, Madison, WI

Completed studies demonstrating that E2F-1 null mutation reduces human papillomavirus-16 (HPV-16) E7 oncoprotein induced proliferation, differentiation and apoptosis in the ocular lens of transgenic mice.
Conducted studies showing that low dose ionizing radiation appears to increase cell survival and alter the cell cycle distribution of radio-resistant U1-Mel cells.

Education

Honors, Awards, and Certifications

National Research Service Award (NRSA) Recipient, 1995-1998, University of Wisconsin, Madison
John W. Strohbehn Medal for Excellence in Biomedical Research Recipient, 1994, Dartmouth College, Hanover, NH.�Awarded annually to the graduating Ph.D. candidate who best exemplifies a scientific scholar, personal qualities of intellectual curiosity, dedication, commitment to the pursuit of new scientific knowledge and to teaching, and a sense of social responsibility to the research community�.
Brigid Leventhal Trainee Travel Award Recipient, American Association of Cancer Research, 1993.
Norris Cotton Cancer Center Predoctoral Fellowship, Dartmouth Medical School, 1993.

Publications